Contaminated
supplements from the intentional addition of hidden pharmaceuticals continues
to plague the industry. Undeclared drugs
were discovered in 746 supplement brands between 2007 and 2016, according to
evidence gleaned in an original investigation of data from the U.S. Food and
Drug Administration (FDA).

The results were published October 12, 2018 by the authors of the quality improvement study that evaluated
the agency’s records.1

A total of 146 dietary
supplement companies were implicated. Most adulterated products with unlabeled
drugs were marketed for sexual enhancement (46%), weight loss (41%), or muscle
building (12%). One hundred fifty-seven products (20%) contained more than one
unapproved ingredient. Fourteen others were masqueraded to assist with various
conditions, primarily inflammation due to arthritis and joint pain, but also
including muscle pain, osteoporosis, bone cancer, sleep issues, gout and
prostate health.1

Commenting on the lack
of supplement quality and safety, the authors warned: "These products have
the potential to cause severe adverse health effects owing to accidental
misuse, overuse, or interaction with other medications, underlying health
conditions, or other drugs within the same dietary supplement.”1

The most common
adulterants were sildenafil for sexual enhancement supplements, sibutramine for
weight loss supplements and synthetic steroids or steroid-like ingredients for
muscle building supplements. Twenty-eight products were named in 2 or 3
warnings more than 6 months apart yet remained for sale on the market. Of these
products, 19 were reported to contain new unapproved ingredients in the second
or third warning, consistent with the assumption that the FDA found the product
to be adulterated more than once.1

Contaminated supplements still on market, even after FDA warnings

“Active
pharmaceuticals continue to be identified in contaminated supplements, even
after FDA warnings,” the researchers concluded. The study was led by Madhur Kumar, of the California Department
of Public Health's Food and Drug Branch and was published in the online Journal of the American Medical
Association’s JAMA Network Open.1

According
to the above study, more than 50% of adults in the United States consume
supplements, fueling a $35 billion industry.
Dietary supplements include vitamins, minerals, botanicals, amino acids,
enzymes, probiotics,
protein powders and other forms, such as a bar, that according to the FDA are classified as a subset of foods, not drugs, and
must be labeled a dietary supplement.1,2

In a comment on
supplement quality and safety, researchers cited a previous study that found dietary
supplement use was associated with 23 000 emergency department visits and 2000
hospitalizations in the United States each year. Serious adverse events
reported with the use of dietary supplements include stroke, acute liver
injury, kidney failure, pulmonary embolisms, and death.1

FDA: Dietary Supplements are not intended to treat or prevent disease

Dietary supplements are
not intended to treat or prevent disease. If a supplement’s label promotes the
prevention or cure for a specific disease or condition, the FDA considers the
product as an unapproved—and thus illegal—drug.3

Whenever a manufacturer
makes a structure/function claim—how the ingredients affects the structure or
function of the body—it must provide the following label disclaimer:

“This statement has
not been evaluated by the FDA. This
product is not intended to diagnose, treat, cure, or prevent any disease.”

Only a drug can
legally make such a claim 4

FDA does not approve supplements. Consumers are the risk-takers

The following disclaimer appears on the FDA
web page, Dietary
Supplements—How to Report a Problem:

“FDA does not approve dietary supplement products before they are sold to the
public. Therefore, it is particularly important for consumers, health
professionals, and industry members to report serious health-related reactions
or illnesses (also known as adverse events) to FDA, so we can take action
to protect thepublic from unsafe products.”5

The consumer is responsible for detecting the
possibility of contaminated supplements. The FDA depends on reports of
adverse health reactions to help identify potentially harmful products.
Once the FDA confirms a tainted supplement, it initiates enforcement measures
with the manufacturer, including mostly voluntary recalls.

On its web page, Tainted Products
Marketed as Dietary Supplements, the FDA warns the public of tainted
supplements and publishes the following disclaimer:

“This list only includes a small fraction of the potentially hazardous
products with hidden ingredients marketed to consumers on the internet and in
retail establishments. FDA
is unable to test and identify all products marketed as dietary supplements on the market that have
potentially harmful hidden ingredients. Even if a product is not included
in this list, consumers should exercise caution before using certain products.”6

Industry insider fears more than 1000 marketed brands contain drugs

The
problem of contaminated supplements appears to have grown in scope in recent
years, with 57 percent of all warnings having been issued since 2012, the
researchers said.1

"Back
in 2009, it appeared that there might be less than 150 brands of supplements
that contain drugs," said Dr. Pieter Cohen in an editorial that
accompanies the new analysis. "Now it's clear that there are well over
1,000 brands of supplements that contain active drugs."1

"Over
the past decade, ever since I first began tracking the problem, I have only
seen the number of supplements adulterated with drugs increase rapidly,"1

Dr.
Cohen is a general internist with the Cambridge Health Alliance, and an
associate professor at Harvard Medical School in Boston. He has long been a critic of the FDA and weaknesses in the laws that govern the industry.7,8,9

In 2009, Dr. Cohen’s perspective on impaired supplement
quality, American Roulette—Contaminated
Dietary Supplements, he wrote: “Lenient regulatory oversight of dietary
supplements, combined with the FDA’s lack of resources, has created a
marketplace in which manufacturers can introduce hazardous new products with
virtual impunity. Under current
regulations, dietary supplements are presumed to be safe with very little
control.”9

How can contaminated supplements escape FDA
scrutiny?

Contaminated
supplements slip through cracks of weakness in the current Good Manufacturing
Practices (cGMP) rules. The cGMP does not require standardized raw materials
testing by manufacturers. Instead, it
allows each company to follow its own protocols, requiring only “a minimum of
at least one test. Nor do the regulations require pre-market
testing for efficacy. And, the FDA never even
sees the product pre-market.

The
cGMP is under the umbrella of the industry-friendly1994 Dietary Supplement
Health and Education Act (DSHEA). The
FDA is not authorized to review dietary supplement products for safety and
effectiveness before they are marketed, according to the FDA web page Dietary Supplements: What You Need to Know.10

Quoting
the FDA: “Manufacturers are required to produce dietary supplements in a
quality manner and ensure that they do not contain contaminants or impurities
and are accurately labeled according to the cGMP and labeling regulations.”10.

FDA warns public after it confirms contaminated supplements

When the FDA identifies contaminated
supplements already on the market, it publishes public warnings. For example,
an FDA Public Notification was issued October 30, 2017 for Linsen
Double Caulis Plus, a
tainted supplement containing hidden drug ingredients. The notification advises
consumers not to purchase the product, which was promoted on various websites
for joint pain, gout, and back pain. 6B

The agency’s laboratory analysis confirmed the
supplement was violated. It was intentionally
spiked (but not labeled) with dexamethasone, a pharmaceutical corticosteroid
commonly used in short-term situations to treat inflammatory conditions (like
rheumatoid arthritis) and may not be appropriate for all patient cases.6B

Whenever
the FDA discovers supplement quality undermined by undeclared drugs, it changes
the dietary supplement classification
to an unapproved new drug classification. A voluntary recall is initiated. There
have been many supplement recallsof
products promoted for arthritis pain and joint discomfort that contain illegal
hidden drugs.

The FDA does not have the resources to conduct
facilities inspections of manufacturers, except for a small percentage of 15,000
registered producers.11 During these
inspections, FDA has found some supplement companies conduct only superficial testing or none at all.

Weak regulations leave manufacturers on the
“honor system”

Under the cGMP,
dietary supplement manufacturers are expected to make quality products without
FDA approval and to market them without the FDA ever inspecting the finished
product. They’re
on the “honor system” to follow the rules to ensure quality and safety.

“The honor
system isn’t working,” John Bradley, the editor in chief of Nutrition
Business Journal, wrote in an editorial February 2, 2015. “The best way forward
for the nutritional supplements industry will be to accept at least a bit more
oversight. However well-intentioned the DSHEA might have been, that 1994
law opened the door to cheating and malfeasance that, even if committed by only
a minority of players, is destroying public trust.12

“You may not be buying what you think you’re
buying, and even if you are, if might not do you any good,” Bradley said. “That’s
not an argument the industry can press-release its way out of. Consumers are no longer willing to accept a
system in which anyone can sell anything until it’s proven to be ineffective or
dangerous,” he added, while calling for changes in the DSHEA.12

In the article, Five Questions to Ask
When Considering Health Supplements, in Frontline of
PBS.org on January 18, 2016, the author, Katie Worth, comments that under the
cGMP/DSHEA “the FDA does not evaluate a supplement’s contents or effectiveness
before it hits the shelves. Even then, the agency has only a modest
capacity to test the pills. The result is a more than $30 billion
industry that is largely regulated by the honor
system.” 13

The following quote appears in the WebMD archived
article, Supplements don’t benefit prostate cancer patients by
Alan Mozes, HealthDay News on October 19, 2015: “Facilities
involved in manufacturing dietary supplements must register with the FDA, but
manufacturers and distributors are on the honor
system when it comes to the truth of labeling claims.”14

Avoid
contaminated supplements: Choose the gold standard leader

To avoid purchasing contaminated supplements,
the FDA recommends that consumers find the best supplement quality by doing their homework.. As we've framed in this
article, Big Brother isn't in your corner to protect you from
dietary supplements. They're foods, not pharmaceutical drugs, and we’ve noted that compared to pharmaceuticals, regulations to market supplement industry
products are weak and poorly enforced, to put it mildly.

To find the best supplement quality, consider the
following questions:

Are your dietary supplements for arthritis or
gout the best that money can buy?

The reason most companies cannot answer YES to
most questions is because regulations don’t say they have to. Why should
they go to the extra expense? While this sounds incredible, it's 100% true.

If you’re considering organic dietary supplement quality to
improve your health and arthritis symptoms, look for trusted brands from
companies in business for some time. In the dietary supplement market, you get
what you pay for—too low in cost could translate to lower quality and less
results. Here is a link to 30 Questionsto help you find the best dietary supplement
company. When we use products from this industry leader (since 1956) we don't have to worry about contaminated supplements.

Contaminated Supplements Page Disclaimer: Health statements on this contaminated supplements
page have not been evaluated by the Food and Drug Administration. These products
are not intended to diagnose, treat, cure, or prevent any disease.

Natural Supplements. Glucosamine, boswellia, GLA, Lecithin, Vit-E and the best omega-3 fish oil are among dietary supplements that provide alternative treatment to painkilling drugs for arthritis with minimal side effects. Click here for more information

Health statements have not been evaluated by the Food & Drug Administration.
This site is not intended to diagnose, treat, cure, or prevent any disease.
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